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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePrecision Montage MRI Spinal Cord Stimulator System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS308
Date Received12/12/2017
Decision Date03/12/2018
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an update to the Precision Montage and Precision Montage MRI Spinal Cord Stimulator (SCS) System firmware to adjust the temperature sensor calibration with an aim to improve the accuracy of the sensor reading, associated changes to the Printed Circuit Board Assembly and device level Automated Test Equipment software, and rework of the IPG devices that failed the device level temperature sensor test.
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